15 results
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7ms
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Sources: EU EUDAMED, US FDA
Philips DuraDiagnost stationary X-ray system
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·September 7, 2016
BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01
FDA Enforcement
Class II
·Terminated·Medtronic·March 22, 2017
BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01
FDA Enforcement
Class II
·Terminated·Medtronic·March 22, 2017
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
FDA Enforcement
Class II
·Terminated·Vascutek, Ltd.·October 6, 2021
Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field Safety Notice ( FSN MA-FCO79500316 ) QLAB Quantification Software. QLAB version 10.0, 10.1 and 10.1.1 with a2DQ and/or aCMQ plug-ins are affected. Catalog # 795041 and Part # 989605315491 Designed to view and quantify image data acquired on Philips Healthcare ultrasound products.
FDA Enforcement
Class II
·Terminated·Philips Ultrasound, Inc.·December 24, 2014
(1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes. (2) JOBST Compri2 lite, REF 76271-02, containing 2 components, one plastic-wrapped padding (as is contained in REF 76271-01) and one plastic wrapped compression bandage with a compression of approximately 20-30mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes.
FDA Enforcement
Class II
·Terminated·BSN Medical Inc·June 15, 2022
VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, peripheral, and coronary vasculature. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel. The VIA 27 Microcatheter is contraindicated for use with liquid embolic materials, such as n-butyl 2-cyanoacrylate or ethylene vinyl alcohol & DMSO (dimethyl sulfoxide).
FDA Enforcement
Class II
·Terminated·Sequent Medical Inc·November 2, 2016
TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 22, 2014